Pharmacovigilance

![]() Each pharmaceutical company is legally obliged to create a pharmacovigilance system for the purpose of collecting and evaluating the effects of suspected adverse reactions. This system must respect the principles set out in the Good Pharmacovigilance Practices (GVP). The holder of the marketing authorization must ensure that he has established an appropriate system of pharmacovigilance and risk management in order to assume the responsibility for its products placed on the market and to ensure the appropriate actions. |
The goals in pharmacovigilance are:
Every pharmaceutical company shall designate a Qualified Person responsible for pharmacovigilance. A pharmacist with sufficient experience in this field may seek recognition as a person in charge for pharmacovigilance with the FAMHP. The following pharmacovigilance system processes must be guaranteed under supervision:
|